A Study of JNJ-68284528 Out‐of‐Specification (OOS) for Commercial Release in Participants with Multiple Myeloma
Last Updated   December 21, 2022 - 00:00
OVERVIEW
-
Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
sites -
Status
Recruiting
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out‐of‐specification (OOS).
CONDITIONS
- Multiple Myeloma
ELIGIBILITY
Inclusion Criteria:
- • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
- • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re‑manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
- • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
- • Meets the criteria to receive lymphodepleting chemotherapy
- • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
Exclusion Criteria:
- • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
- • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
- • Hepatitis B infection
- • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
- • Seropositive for human immunodeficiency virus (HIV)
- • Uncontrolled autoimmune disease
DETAILS
LOCATIONS
Country (2) | City or Province (25) | Status |
United States | Atlanta, GA Emory University |
Recruiting
|
United States | Boston, MA Beth Israel Deaconess Medical Center |
Not yet recruiting
|
United States | Boston, MA Dana-Farber Cancer Institute |
Recruiting
|
United States | Boston, MA Massachusetts General Hospital |
Recruiting
|
United States | Charlotte, NC Levine Cancer Institute |
Recruiting
|
United States | Chicago, IL Northwestern University |
Recruiting
|
United States | Denver, CO Colorado Blood Cancer Institute |
Recruiting
|
United States | Detroit, MI Barbara Ann Karmanos Cancer Institute |
Recruiting
|
United States | Duarte, CA City of Hope |
Recruiting
|
United States | Hackensack, NJ Hackensack University Medical Center |
Recruiting
|
United States | Houston, TX MD Anderson Cancer Center |
Recruiting
|
United States | Jacksonville, FL Mayo Clinic |
Withdrawn
|
United States | Miami, FL University of Miami Sylvester Comprehensive Cancer Center |
Not yet recruiting
|
United States | Milwaukee, WI Medical College Of Wisconsin |
Recruiting
|
United States | New York, NY Memorial Sloan Kettering Cancer Center |
Recruiting
|
United States | New York, NY Mount Sinai Medical Center |
Recruiting
|
United States | Pittsburgh, PA University of Pittsburgh Medical Center |
Recruiting
|
United States | Rochester, MN Mayo Clinic - Rochester |
Not yet recruiting
|
United States | Saint Louis, MO Washington University School of Medicine |
Recruiting
|
United States | San Francisco, CA University of California, San Francisco |
Recruiting
|
United States | Seattle, WA University of Washington-Fred Hutchinson Cancer Research Center |
Not yet recruiting
|
United States | Stanford, CA Stanford University Medical Center |
Recruiting
|
United States | Tampa, FL H. Lee Moffitt Cancer Center and Research Institute |
Not yet recruiting
|
United States | Westwood, KS Kansas University Medical Center |
Recruiting
|
Japan | Nishinomiya-shi, 28 Hyogo Medical University Hospital |
Not yet recruiting
|
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Corresponds to individual site.